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Abstract

QUANTITATIVE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR TRIFLUNOMIDE IN PHARMACUTICAL DOSAGE FORM

Krupa N. Patel*, Khushbu K. Patel, L. M. Prajapati, H. D. Karen and C. N. Patel

ABSTRACT

Developed method is a rapid, simple and Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method for determination of teriflunomide. The HPLC separation was achieved on Agilent-1260 Infinity series instrument with C18- 5μm, Waters Column. (150X4.6 mm, 5μm) using a mobile phase of acetonitrile and water solution (40:60; v/v) at a flow rate of 1.0 ml/min. The method was validated for specificity, linearity, precision, accuracy, robustness and ruggedness. The elution of peak was rapid which takes about 10 minutes. The method was found to be simple, specific, precise, accurate, linear and reproducible. The method can be applied for the quality control of commercial teriflunomide API (active pharmaceutical ingredient) to quantify the drug and to check the formulation content uniformity and purity of drug.

Keywords: Teriflunomide, API, RP-HPLC validation.


[Full Text Article]

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